Prospective Follow up of Minimally Invasive Chest Wall Surgery After Trauma

NCT04710602 | Completed

• 1 other identifier: FoU-274457
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the outcome of a muscle sparing, minimally invasive open surgical technique for unstable ribcage injuries after trauma. The investigators will compare the results from the study participants to a historical cohort who were operated with a different surgical technique with large incisions and simultaneous thoracotomy.

Conditions

Rib; Fracture, Multiple, With Flail Chest

Keywords

Chest wall; Trauma; Minimally invasive; Surgery; Muscle sparing

Outcome Measures

Primary Outcomes (5)

• Vital capacity of the lungs.

  Vital capacity (VC) measured with spirometry.

  One year after surgery.

• Forced vital capacity of the lungs.

  Forced vital capacity (VC) measured with spirometry.

  One year after surgery.

• Forced expiratory volume of the lungs.

  Forced expiratory volume in 1 second (FEV1) measured with spirometry.

  One year after surgery.

• Forced expiratory volume percent of the lungs.

  Forced expiratory volume in 1 second divided with forced vital capacity, measured with spirometry.

  One year after surgery.

• Peak expiratory flow of the lungs.

  Peak expiratory flow measured with spirometry.

  One year after surgery.

Secondary Outcomes (7)

• Disability

  Six months and one year after surgery.

• Physical activity

  Six months and one year after surgery.

• Shoulder mobility

  Six months and one year after surgery.

• Respiratory movement

  Six months and one year after surgery.

• Strength of respiratory muscles

  Six months and one year after surgery.

Study Arms (2)

Minimally invasive

Patients who underwent surgery with a muscle sparing, minimally invasive technique for unstable chest wall after trauma.

Procedure: Minimally invasive surgical fixation of unstable rib cage

Historical control

Patients who underwent surgery with large incisions and simultaneous thoracotomy for unstable chest wall after trauma.

Procedure: Large incision surgical fixation of unstable rib cage.

Interventions

Minimally invasive surgical fixation of unstable rib cage PROCEDURE

Minimally invasive and muscle sparing surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes).

Minimally invasive

Large incision surgical fixation of unstable rib cage. PROCEDURE

Surgical fixation of ribs and/or sternum in an unstable segment of the chest wall (flail chest) with titan plates or medullary nails (MatrixRib Fixation System, DepuySynthes). Large non muscle sparing incision with simultaneous thoracotomy.

Historical control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients surgically treated at our trauma ward for unstable chest wall due to trauma. Consecutive sampling.

You may not qualify if:

• Severe head injury (Abbreviated Injury score (AIS) \>3)
• Spinal injury
• Neurological or musculoskeletal disease affecting chest wall mobility

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Related Publications (7)

• Bemelman M, van Baal M, Yuan JZ, Leenen L. The Role of Minimally Invasive Plate Osteosynthesis in Rib Fixation: A Review. Korean J Thorac Cardiovasc Surg. 2016 Feb;49(1):1-8. doi: 10.5090/kjtcs.2016.49.1.1. Epub 2016 Feb 5.

  PMID: 26889439 BACKGROUND

• Caragounis EC, Fagevik Olsen M, Pazooki D, Granhed H. Surgical treatment of multiple rib fractures and flail chest in trauma: a one-year follow-up study. World J Emerg Surg. 2016 Jun 14;11:27. doi: 10.1186/s13017-016-0085-2. eCollection 2016.

  PMID: 27307787 BACKGROUND

• Granetzny A, Abd El-Aal M, Emam E, Shalaby A, Boseila A. Surgical versus conservative treatment of flail chest. Evaluation of the pulmonary status. Interact Cardiovasc Thorac Surg. 2005 Dec;4(6):583-7. doi: 10.1510/icvts.2005.111807. Epub 2005 Sep 15.

  PMID: 17670487 BACKGROUND

• Granhed HP, Pazooki D. A feasibility study of 60 consecutive patients operated for unstable thoracic cage. J Trauma Manag Outcomes. 2014 Dec 30;8(1):20. doi: 10.1186/s13032-014-0020-z. eCollection 2014.

  PMID: 25642282 BACKGROUND

• Marasco SF, Davies AR, Cooper J, Varma D, Bennett V, Nevill R, Lee G, Bailey M, Fitzgerald M. Prospective randomized controlled trial of operative rib fixation in traumatic flail chest. J Am Coll Surg. 2013 May;216(5):924-32. doi: 10.1016/j.jamcollsurg.2012.12.024. Epub 2013 Feb 13.

  PMID: 23415550 BACKGROUND

• Tanaka H, Yukioka T, Yamaguti Y, Shimizu S, Goto H, Matsuda H, Shimazaki S. Surgical stabilization of internal pneumatic stabilization? A prospective randomized study of management of severe flail chest patients. J Trauma. 2002 Apr;52(4):727-32; discussion 732. doi: 10.1097/00005373-200204000-00020.

  PMID: 11956391 BACKGROUND

• Westin EO, Olsen MF, Caragounis EC. Comparison of long-term outcome between muscle sparing and non-muscle sparing surgical techniques in rib plating. Eur J Trauma Emerg Surg. 2025 May 20;51(1):212. doi: 10.1007/s00068-025-02881-z.

  PMID: 40392360 DERIVED

MeSH Terms

Conditions

Fractures, Bone; Wounds and Injuries

Study Officials

• Erik Westin, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: January 14, 2021
• Study Start: January 15, 2021
• Primary Completion: May 5, 2022
• Study Completion: May 11, 2023
• Last Updated: May 1, 2026

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)